Outcomes After Weight Loss Surgery in Low-Risk Patients

Weight Loss Clinical Trial

Official title:

Evaluation of Patient Reported Outcomes After Weight Loss Surgery in Low-Risk Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05699083
• Other study ID #: MF001
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2022
• Est. completion date: January 12, 2026

Study information

• Verified date: January 2023
• Source: Dr. Feiz & Associates
• Contact: Negin Fadaee, BS MPH
• Phone: 818-326-5515
• Email: negin[@]drfeiz.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to determine patient-reported outcomes after weight loss surgery, including changes in health, mood, quality of life, health satisfaction, and emotional health, in low-risk patients. Weight loss surgery has been well studied for patients with body mass index (BMI) 35 kg/m^2 or more and those with weight-related medical problems who have a BMI 30 kg/m^2 or more. However, outcomes after weight loss surgery in patients with BMI under 35 kg/m^2 and without co-morbidities have not been well studied.

Description:

The purpose of this research is to determine patient-reported outcomes after weight loss surgery in low-risk patients. Weight loss surgery has been well-studied for patients with body mass index (BMI) 35 kg/m^2 or more and those with weight-related medical problems who have a BMI 30 kg/m^2 or more. Weight-related medical problems, also called co-morbidities, can include diabetes mellitus, hypertension, sleep apnea, and degenerative joint diseases. The surgery is considered safe and effective. Outcomes after weight loss surgery in patients with BMI under 35 kg/m^2 and without co-morbidities have not been well studied. The investigators' purpose is to study patient-reported outcomes after weight loss surgery in patients with BMI between 30 kg/m^2 and 34.5 kg/m^2 without co-morbidities. These include changes in health, mood, quality of life, health satisfaction, and emotional health.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 12, 2026
• Est. primary completion date: January 12, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with BMI between 30 kg/m2 and 34.5 kg/m2 without co-morbidities who are medically cleared to undergo cosmetic weight loss surgery.

• Written informed consent obtained from the subject or the subject's legal representative and the ability for the subject to comply with the requirements of the study.

Exclusion Criteria:

• Patients who are pregnant.

• Patients with BMI below 30 kg/m2.

• Patients with BMI above 34.5 kg/m2.

• Patients who have co-morbidities including, but not limited to, diabetes mellitus, hypertension, sleep apnea, and degenerative joint disease.

• Patients who are not medically cleared to undergo weight loss surgery.

Related Conditions & MeSH terms

• Bariatric Surgery
• Body Weight
• Weight Loss

Intervention

Other:
• Body Image/Self-Esteem Questionnaires
Pre-operation and post-operation questionnaires to assess factors including but not limited to body image, quality of life, and self-esteem.

Locations

Country	Name	City	State
United States	Dr. Feiz and Associates	Beverly Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Feiz & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Perception of General Health	A survey will be administered to determine changes in one's self-assessed general health.	0, 1, 3, 6, 12 months
Primary	Change in Perception of Body Image	Surveys will be administered to determine changes in one's self-assessed body image.	0, 1, 3, 6, 12 months
Primary	Change in Perception of Quality of Life	Surveys will be administered to determine changes in one's self-assessed quality of life.	0, 1, 3, 6, 12 months